Guangzhou-Based Bio-Thera Secures $28.59M and Regains Global Rights to Tocilizumab Biosimilar BAT1806 in Zero-Cost, Three-Way Win Deal

On April 1, Organon LLC (hereinafter referred to as “Organon”) acquired the U.S. regulatory and commercialization rights for the intravenous formulation of TOFIDENCE™ (BAT1806, tocilizumab), owned by Biogen, through an acquisition. Organon will be responsible for commercialization activities in the United States, including marketing and sales of the product, while the developerBio-Thera will be responsible for manufacturing, production, and commercial supply.。

The agreement states that Organon will not only pay Biogen an undisclosed upfront payment but also assume Biogen’s obligations to pay tiered royalties and milestone payments to Bio-Thera based on net sales and annual net sales under the license agreement. The $28.59 million upfront payment previously received by Bio-Thera remains unaffected and does not need to be refunded.

Notably, as agreed upon by both parties through mutual consultation,On the same day, Bio-Thera regained all global rights to develop, manufacture, and commercialize the subcutaneous formulation of BAT1806, as well as all global rights excluding the United States for the intravenous formulation of BAT1806, from Biogen, without any obligation to pay upfront fees, milestone payments, or royalties.Biogen no longer holds any rights related to BAT1806.

“How to Achieve ‘Zero-Cost Recovery’? What Are the Considerations and the ‘Triple Win’ Behind the Secondary Transfer?”

According to Biogen’s 2024 annual report, BAT1806 contributed$1.1 millionrevenue, which is not prominent within its $793 million biosimilars segment.Further, the U.S. approval of BAT1806 did not come at the peak of its former parent company Biogen’s performance.

In April 2021, Bio-Thera licensed the exclusive global rights (including development, manufacturing, and commercialization) for BAT1806 (tocilizumab) injection to Biogen in all markets outside China (including Mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan), for a total maximum consideration of $120 million. Subsequently, BAT1806 received FDA approval for marketing in September 2023 and was officially launched for sale in the United States in May 2024.

This launch and commercialization milestone coincides with Biogen’s plan to divest its biosimilars business.It is reported that Biogen had planned to divest its biosimilars business as early as 2023. However, in 2024, sales of Biogen’s flagship products plummeted while subsequent growth failed to gain momentum, leading to the retention of its biosimilars division.

In 2025, Bio-Thera’s biosimilar segment, with $793 million in revenue, accounted for approximately 10.99% of the company’s total revenue from the previous year. Cost control and streamlining measures for this segment have now been implemented, with BAT1806 being the first asset to be optimized.

The successful secondary transfer coincided with a critical juncture in Organon’s sustained push to expand its biosimilars portfolio, enabling BAT1806 to seize the opportunity.

Organon CEO Kevin Ali pointed out that biosimilars remain a key growth driver for the company, and this acquisition complements its existing business, helping to expand Organon’s product portfolio in the field of immunotherapy. By leveraging the team’s commercial expertise and market access capabilities, BAT1806 holds considerable potential for market growth.

Bio-Thera told Jiemian News that the business adjustment was made based on a consensus reached through tripartite negotiations.For Bio-Thera, the developer and manufacturer, this acquisition is not only expected to further expand the U.S. market for BAT1806 and increase related royalty and license fee payments, but also allows it to reclaim all rights to both dosage forms of BAT1806 across multiple potential global markets “without lifting a finger.”

For Bio-Thera at present, “zero-cost recovery” can be described as significant in terms of asset allocation and news sentiment."Providing timely assistance."According to the 2024 performance flash report released in February, revenue reached RMB 743 million in 2024, a year-on-year increase of 5.44%. However,It also failed to reverse the operational losses, with profits experiencing a significant decline.Operating loss amounted to RMB 507 million, representing an increase in loss of RMB 117 million compared to the same period last year; equity attributable to owners of the parent company stood at RMB 704 million, a decrease of 41.96% from the beginning of the year; net assets per share attributable to owners of the parent company were RMB 1.70, a decrease of 41.98% from the beginning of the year.

In particular, Bio-Thera’s explanation explicitly stated that Tocilizumab Injection (BAT1806) has added overseas supply operations; however, as its overseas partners are still in the early stages of expansion, the overall increase in operating revenue remains modest.

On the other hand, the recapture of global rights (excluding the United States) for both formulations may serve as an added advantage for Bio-Thera’s future growth.

BAT1806, the centerpiece of the secondary transaction, is marketed under the brand name Shiruili® in China and TOFIDENCE™ in the United States. It is a tocilizumab biosimilar developed by Bio-Thera in accordance with the relevant guidelines for Roche’s Actemra. The product has received marketing approval in China, the United States, and Europe, and it is the first tocilizumab biosimilar approved by the U.S. Food and Drug Administration (FDA).

BAT1806 is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). It specifically binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signal transduction mediated by sIL-6R and mIL-6R. Its approved indications in the United States include: moderate to severe active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and the treatment of coronavirus disease 2019 (COVID-19).

Shi Ruili^®It was approved for marketing in China in January 2023, with approved indications including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), becoming the first tocilizumab biosimilar approved in China (first generic).Just three days later, Shi Ruili^®Tocilizumab Injection has been included in the National Reimbursement Drug List, covering three indications: rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS).

Not only does it benefit from the NMPA’s “first generic” advantage, but BAT1806 also faces limited competition in the U.S. market.Including Roche’s originator Actemra, only four tocilizumab products have been approved for marketing, including Fresenius Kabi’s Tyenne and Avtozma from Celltrion, which was just approved in February this year. Meanwhile,From approval to its official market launch in May 2024, Bio-Thera and its partners have seized the first-mover advantage by establishing a mature production-supply chain, with a market window still available for the first generic version and formal commercial sales.

In the long term, BAT1806 still has a broad market of unexplored dosage forms and indications.

Drawing an analogy to Roche’s strategy for expanding the originator tocilizumab in China,First is the innovation in drug dosage forms:In 2013, Actemra® was approved in China for use in combination with methotrexate (MTX) or other DMARDs for the treatment of rheumatoid arthritis (RA); in 2022, its subcutaneous injection formulation was approved in China, ushering in a “dual-formulation” era; in 2023, monotherapy with the subcutaneous injection formulation was approved in China, filling the clinical treatment gap for RA patients intolerant to MTX and further expanding its application scenarios and market presence.

Secondly, as an immunotherapy targeting the interleukin-6 (IL-6) receptor, tocilizumab still has room for continued expansion into immune-mediated diseases and related indications.The indications for BAT1806 approved in the United States include moderate-to-severe active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and the treatment of coronavirus disease 2019 (COVID-19). In addition, BAT1806 and Actemra® are approved in various markets for the treatment of cytokine release syndrome (CRS).

In response to Jiemian News, Bio-Thera stated that the company has not yet established its own overseas team and is more likely to seek new licensing partnerships for the rights to BAT1806 in other international markets.

This means that Bio-Thera still has the potential to secure new business development (BD) partnerships through the global rights to the subcutaneous formulation of BAT1806 and the global rights to the intravenous formulation excluding the United States.

Reference: Jiemian News, “Bio-Thera Responds to Resale of Monoclonal Antibody Listed in the U.S.”